Recall Z-2147-2024— Ethicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ethicon, Inc., initiated 2024-05-10. It names 2 FDA 510(k) clearances: K212380, K061037. Product: PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H. Reason: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection ..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-10
- Firm location
- Raritan, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture
- K061037 — PDS PLUS ANTIBACTERIAL SUTURE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Data sourced from openFDA. This site is unofficial and independent of the FDA.